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EU MDR Article 61 Clinical Evaluation
The European Union (EU) Medical Device Regulation 2017/745 (EU MDR) aims to ensure a high level of...
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Challenges of Demonstrating Biological Equivalence per ISO 10993-18 and EU MDR
In the European Union (EU), a device is considered equivalent if it fulfills all the requirements of...
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Regulatory Challenges for Novel Implantable Devices under EU MDR
In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive...
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A Quick Guide to the EU IVDR
The In Vitro Diagnostic Directive (EU) 98/79/EC (IVDD) was introduced over two decades ago to establish the...
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Navigating Biocompatibility: An Introduction to ISO 10993 Series of Standards
Medical device manufacturers should always refer to ISO 10993 Series of Standards in addition to region-specific regulatory...
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FDA’s New Guidance on Nitrosamine and Nitrosamine- Drug Substance Related Impurities and Recommended Acceptable Intake Limits
The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
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Navigating the Complex World of PFAS Regulation for Medical Devices
Per- and poly-fluoroalkyl substances (PFAS) are a group of fluorinated compounds characterized by carbon-fluorine bonds. While some...
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An important downside to eSTAR
If you are keeping abreast of FDA’s medical device efforts, then you know that as of October...
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ISO 10993-17 Revision
The new version of ISO 10993-17 is expected to be published very soon. This is a major...
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Can the safe history of clinical use be used as justification for biocompatibility of a medical device?
Can the safe history of clinical use (no complaints registered in PMS) be used as justification not...
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What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a detailed summary of the evaluation of information pertaining to clinical...
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Quality System Remediation and Root Cause Analysis
Successful quality system remediation relies on understanding why problems arose, generally referred to as “root cause analysis.” ...
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